Recommendation of IV Dose Preparation Practices Using Closed System Transfer Devices (CSTD) for Accurate Dosing [0.03%]
使用封闭系统转运设备(CSTD)推荐IV剂量制备实践以实现准确给药
Qunhui Liu,Ka Po Chu,Armando Cardenas et al.
Qunhui Liu et al.
Accurate dose preparation and administration are critical components in clinical studies to ensure patient safety and drug efficacy. Closed System Transfer Devices (CSTD) are widely used for the preparation and administration of hazardous d...
Short-Term Immunosuppression in Rats Induces Prolonged Immune Tolerance Towards a Human Monoclonal Antibody, Erenumab [0.03%]
短期免疫抑制可诱导大鼠对人类单克隆抗体（艾尔建单抗）产生长期免疫耐受性研究
Paridhi Gupta,Ashish Srivastava,Josiah T Ryman et al.
Paridhi Gupta et al.
Administration of human therapeutic proteins such as monoclonal antibodies (mAb) to animals during preclinical drug development often leads to the development of anti-drug antibodies (ADA). ADA may reduce the systemic exposure of the mAb by...
Social Inequality and Antimicrobial Resistance: An Interconnected Global Problem [0.03%]
社会不平等与抗菌素耐药性：一个相互关联的全球问题
Antonio Vitiello,Andrea Zovi
Antonio Vitiello
Investigations of Influence of Antibody Binding Kinetics on Tumor Distribution and Anti-Tumor Efficacy [0.03%]
抗体结合动力学对肿瘤分布和抗肿瘤疗效影响的研究
Ping Chen,Brandon M Bordeau,Wenqiu Zhang et al.
Ping Chen et al.
The pharmacokinetics of antibodies with varied binding kinetics were simulated to assess the role of affinity and binding microconstants (kon, koff) on tumor exposure and intra-tumoral distribution. Anti-HER2 constructs (trastuzumab, pertuz...
Removal of Excipients from Drug Product may Impact Antibody Characterization of Monoclonal Antibodies [0.03%]
药物产品中去除辅料可能会影响单克隆抗体的抗体表征
Kunal Krishna,Deepika Sarin,Drashti Trivedi et al.
Kunal Krishna et al.
Extensive analytical and functional characterization of a biotherapeutic product is a regulatory requirement, more so for biosimilar products where approval is contingent on the manufacturer's ability to demonstrate comparability of their p...
Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling [0.03%]
基于生理的药代动力学模型建立卡马西平片临床相关标准
Xiaofeng Wang,Longjie Li,Hongyi Yang et al.
Xiaofeng Wang et al.
The purpose of this study was to establish a clinically relevant specification for carbamazepine (CBZ) tablets, a classic narrow therapeutic index drug (NTID), within the Chinese population. By integrating physiologically based pharmacokine...
An Ocular Exposure Prediction for Topical Atropine in Human Using Physiologically Based Pharmacokinetic Modeling [0.03%]
基于生理药代动力学模型的人工泪液联合托吡卡胺滴眼剂眼部暴露预测研究
Aole Zheng,Tian Han,Fengjiao Bu et al.
Aole Zheng et al.
Developing a mathematical model to predict the distribution and bioavailability of atropine in human eyes is an insight approach for clinical practice. This study aims to develop a human ocular physiologically based pharmacokinetic (PBPK) m...
Simultaneous Estimation of fm and FG Values Directly from Clinical Drug-Drug Interaction Study Data [0.03%]
直接从临床药物相互作用研究数据中同时估算fm和FG值
Yumi Cleary,Nicolo Milani,Kayode Ogungbenro et al.
Yumi Cleary et al.
During drug development, the design, interpretation and risk assessment of drug-drug interaction (DDI) are generally performed with physiologically-based pharmacokinetic (PBPK) modelling. Critical parameters are the hepatic metabolic fracti...
Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of Iberdomide [0.03%]
基于模型的药物开发(MIDD)支持伊贝多米德生物药剂学开发的方法学研究
Caroline Sychterz,Ping Chen,Ajay Saxena et al.
Caroline Sychterz et al.
Iberdomide is a BCS III CELMoD™ agent currently under development for treatment of multiple myeloma. Five formulations were used during clinical development, starting with active ingredient in gelatin capsule (AIC), followed by subsequent ...
The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models [0.03%]
更为直观的非线性混合效应模型诊断方法：参考校正视觉预测检查
Moustafa M A Ibrahim,E Niclas Jonsson,Martin Bergstrand
Moustafa M A Ibrahim
The prediction-corrected visual predictive check (pcVPC) is an informative model diagnostic that can offer advantages over the standard visual predictive check (VPC) when heterogenous study designs and adaptive dosing are used. However, a d...